Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment.

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Duke University
Information provided by (Responsible Party):
Duke University Identifier:
First received: November 14, 2013
Last updated: February 10, 2015
Last verified: January 2015

Outpatient childhood obesity treatment has limited efficacy. This study aims to improve the health habits of parents of obese 5-12 year old children enrolled in the Duke Healthy Lifestyles Program by delivering educational and supportive text messages to the parent's mobile device.

Condition Intervention
Pediatric Obesity
Behavioral: Lifestyle counseling
Behavioral: Text Messaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment Through Provider-to-parent Text Messaging.

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Food and Activity Frequency Survey Score [ Time Frame: 3 month post-enrollment ] [ Designated as safety issue: No ]
    Validated lifestyle behavior survey, addresses common behaviors such as beverages, fast food, television time. 20 questions on 4-point Likert.

Secondary Outcome Measures:
  • General Self-Efficacy Survey Score [ Time Frame: 3 month post-enrollment ] [ Designated as safety issue: No ]
    Validated survey measures parental general self-efficacy. 10 questions on a 5-point Likert.

Other Outcome Measures:
  • Change in child's Body Mass Index [ Time Frame: Baseline and 3-month ] [ Designated as safety issue: No ]
    Weight divided by the height squared. Gives indication of whether healthy lifestyle changes lead to short-term weight reduction.

Estimated Enrollment: 50
Study Start Date: September 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lifestyle counseling
The Duke Healthy Lifestyles program is a comprehensive childhood obesity treatment program. Standard of care is active engagement and Lifestyle Counseling of families by nutritionist, physician, mental health provider, and physical therapist. Monthly visits for 1 year are recommended.
Behavioral: Lifestyle counseling
see arm description
Experimental: Lifestyle counseling PLUS text messaging
Patients in this arm will receive full standard of care as described for the Active Comparison group. In addition, parents will be texted daily with a motivational message that provides information and support for healthy behaviors.
Behavioral: Lifestyle counseling
see arm description
Behavioral: Text Messaging
See Arm Description

  Show Detailed Description


Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult aged 18 or older and is the child's primary caregiver ("parent")
  • Child aged 5-12 years
  • Child with age- and gender-specific BMI ≥ 95th percentile
  • Parent has mobile phone with texting plan

Exclusion Criteria:

  • Inability to read and write in English
  • Parent with severe medical or mental health condition limiting ability to attend appointments
  • Plan to move out of state in next 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01989065

Contact: Sarah C Armstrong, MD 919-620-5315

United States, North Carolina
Duke Children's Health Center Recruiting
Durham, North Carolina, United States, 27704
Contact: Sarah C Armstrong, MD    919-620-5315   
Sponsors and Collaborators
Duke University
Principal Investigator: Sarah C Armstrong, MD Duke University Health System
  More Information

No publications provided

Responsible Party: Duke University Identifier: NCT01989065     History of Changes
Other Study ID Numbers: Pro00050555, Pro00050555_RDS
Study First Received: November 14, 2013
Last Updated: February 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Child obesity
childhood obesity
obesity treatment
text messaging

Additional relevant MeSH terms:
Pediatric Obesity
Body Weight
Nutrition Disorders
Signs and Symptoms processed this record on October 09, 2015